Page 75 - 2023 Taiwan Food and Drug Administration Annual Report
P. 75

5Improving Management of Medical
                                                                Devices and Cosmetics

Research Institute, which has greatly boosted    III. Introduction of the
the zeal of all parties to devote themselves to      e-submission and review
the R&D of medical devices. Furthermore, to          system to improve the
increase the professionalism of practitioners,       efficiency of digital
TFDA has promoted the medical device                 management
professional technician system. As of the
end of 2022, a total of 6,800 people had been          On January 21, 2022, the e-submission
registered as medical device technicians and     system for the registration and market
41 online courses had been provided as part of   approval of medical devices was officially
continuing education for technicians.            launched to facilitate the e-submission and
                                                 review of applications for registration and
II. Establishment of sound and                   market approval, contract manufacturing,
   internationally harmonized                    alteration, and extension of Class 2 and Class
   laws and regulations to                       3 medical devices. As of the end of 2022, with
   govern medical devices                        a total of 957 applications, one can see that the
                                                 system has helped to improve the convenience
      In 2022, a total of 12 guidances or        of submitting pre-market applications for
guidelines related to laws and regulations       medical devices. In addition, on March 8, the
of medical devices or review were added or       announcement of “Medical Device Product
revised, including 4 guidances or guidelines     Items Whose Instructions May Be Replaced
related to artificial intelligence/machine-      by Electronic Instructions and Medical Device
learning based technologies and pre-clinical     Firms Shall Indicate the Particulars on the
testing/technical criteria for 8 preclinical     Labels or Package” was made in an effort to
testing/benchmarks and guidance that             promote paperless practice and digitalization.
manufacturers can use as references during the
phases of product development, verification,     IV. Advancement in
and registration and market approval. In             development of innovative
addition, the “Reference for the Use of Real         medical devices
World Data and Real World Evidence To
Support Regulatory Decision-Making for                 To improve the service efficiency and
Medical Devices” was announced to facilitate     effectiveness of the Intelligent Medical
proper utilization of such data by all parties   Device Project Office, in 2022, the Office
and to expedite product development.             actively solicited applications, which resulted
                                                 in 10 applications related to domestically
                                                 manufactured Artificial Intelligent/Machine
                                                 Learning-Based Software as a Medical

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